- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03263780
High Resolution PET-MRI Before Prostate Cancer HIFU
High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy
Study Overview
Detailed Description
This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.
Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.
Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prostate biopsy consisting of ≥ 10 tissue cores sampled
- PSA </=20 ng/mL
- cT1-cT2c
- Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
- Patient considering focal HIFU therapy
Exclusion Criteria:
- Previous local therapy for prostate cancer
- Inability to receive PET tracer
- Inability to receive MRI
- Suggestion of extracapsular extension or seminal vesicle invasion on imaging
- Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
- Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-Fluciclovine
10mCi +/-20% 18F-fluciclovine injection
|
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
Time Frame: At time of post-imaging biopsy
|
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+) |
At time of post-imaging biopsy
|
Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
Time Frame: At time of post-imaging biopsy
|
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+) |
At time of post-imaging biopsy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative Biopsy Rate (Number of Participants With Negative Biopsy)
Time Frame: 6 months following standard HIFU therapy
|
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer.
The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer.
PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Following the tumor mapping study, patients with high grade disease (i.e.
Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe.
Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.
|
6 months following standard HIFU therapy
|
Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
Time Frame: 6 months following standard HIFU therapy
|
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer.
The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer.
PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Following the tumor mapping study, patients with high grade disease (i.e.
Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe.
Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.
|
6 months following standard HIFU therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy Daskivich, MD, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2016-19-DASKIVICH-18F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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